Evaluate the Pharmacokinetics of a Combined Oral Contraceptive (COC) With and Without Obicetrapib

September 14, 2024 updated by: NewAmsterdam Pharma

A Study to Evaluate the Effect of Daily Doses of Obicetrapib Tablets on the Pharmacokinetics of Drospirenone and Ethinyl Estradiol in Healthy Adult Female Subjects

A study to evaluate the impact of Obicetrapib on the PK levels of Drospirenone and Ethinyl Estradiol (COC) in 30 adult female, healthy volunteers.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is an interventional, drug-drug interaction study to evaluate the effect of daily doses of Obicetrapib tablets on the pharmacokinetics of a combined oral contraceptive (COC), Drospirenone and Ethinyl Estradiol.

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Nevada
      • Las Vegas, Nevada, United States, 89121
        • NOVUM

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • Non-pregnant, non-lactating, non-tobacco-, non-nicotine-using female, 18-35 years of age, inclusive, who is a candidate for hormonal contraception (as determined by the Investigator).
  • Subject has a BMI of 18.5-29.9 kg/m², inclusive. BMI will be calculated using Novum Pharmaceutical Research Services Standard Operating Procedures.
  • If the subject is currently using a hormonal method of contraception, the subject is willing and agrees to stop using her hormonal contraceptive throughout the duration of the study and is prepared to abstain from sexual intercourse or use a reliable non-hormonal method of contraception, as outlined below

Exclusion Criteria:

  • Male
  • Have given birth or been pregnant within 3 months before initial dosing, or is currently pregnant, lactating or likely to become pregnant during the study.
  • History of Hypertension, or seated blood pressure for a minimum of 5 minutes >140mmHg systolic, or > 80 mmHg, diastolic at screening

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Sequential Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment B+C: Obicetrapib + Drospirenone/Ethinyl Estradiol (COC)
Obicetrapib 10 mg tablets and Drospirenone (3mg)/Ethinyl Estradiol (0.02mg) tablet
Drug: Obicetrapib
oral administration
Other Names:
  • 10 mg tablet
Drug: Obicetrapib + Drospirenone / Ethinyl Estradiol (COC)
oral administration
Other Names:
  • tablets
Experimental: Treatment B: Obicetrapib
Obicetrapib 10 mg tablets (daily)
Drug: Obicetrapib
oral administration
Other Names:
  • 10 mg tablet
Experimental: Treatment C: Drospirenone/Ethinyl Estradiol tablets (COC)
Drospirenone (3mg)/Ethinyl Estradiol tablets (0.02mg) tablet
Drug: Drospirenone / Ethinyl Estradiol (COC)
oral administration
Other Names:
  • tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Maximum observed plasma concentration (Cmax) of COC
Time Frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Plasma Cmax concentration of COC with and without Obicetrapib
Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Area under the plasma concentration-time (AUC0-τ) curve for COC with and without coadministration with Obicetrapib
Time Frame: Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)
Plasma AUC0-τ for COC with and without coadministration of Obicetrapib
Upon completion of Treatment C (Day -6) and Treatments B+C (Day 12)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

NewAmsterdam Pharma

Collaborators

Novum

Investigators

  • Principal Investigator: Kent A Swaine, Novum Pharmaceutical Research Services, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 5, 2024

Primary Completion (Actual)

April 25, 2024

Study Completion (Actual)

April 26, 2024

Study Registration Dates

First Submitted

February 1, 2024

First Submitted That Met QC Criteria

February 1, 2024

First Posted (Actual)

February 8, 2024

Study Record Updates

Last Update Posted (Actual)

September 19, 2024

Last Update Submitted That Met QC Criteria

September 14, 2024

Last Verified

September 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TA-8995-13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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